Emvistegrast trial results announced by Gilead Sciences on October 19, 2026, showed that its investigational oral treatment met the primary endpoint in a Phase 2 ulcerative colitis study. At 12 weeks, 66% of patients receiving the 200 mg dose achieved a clinical response, compared with 37% receiving placebo. Gilead plans to begin a Phase 3 monotherapy study in 2027.
Key Takeaways
- The 200 mg dose produced a 29-percentage-point advantage over placebo in clinical response at week 12.
- Clinical remission reached 31% with the treatment versus 8% with placebo.
- Emvistegrast remains investigational and has not been approved anywhere globally.
Table of Contents
- Emvistegrast trial shows improvement at 12 weeks
- Safety findings cover all active-dose groups
- Phase 3 is planned, not yet underway
- Conclusion
Emvistegrast trial shows improvement at 12 weeks
Gilead’s Phase 2 SWIFT results announcement described a study in adults with moderately to severely active ulcerative colitis. The findings came from its 12-week, placebo-controlled induction phase and were presented at United European Gastroenterology Week 2026 in Barcelona.
The primary endpoint measured clinical response using the modified Mayo clinical score. Clinical remission was a separate secondary endpoint; the response rate should therefore not be interpreted as the proportion of patients reaching remission.
Gilead said the 200 mg dose met the primary endpoint and showed significant differences across multiple secondary measures based on nominal p-values. Mucosal healing was achieved by 24% of patients receiving that dose, compared with 10% on placebo.
| Item | Details |
|---|---|
| Treatment format | Investigational once-daily oral therapy. |
| Dose groups | 200 mg, 75 mg and 25 mg, plus placebo. |
| Study allocation | Participants randomized equally among four groups. |
| Longer-term design | Maintenance phase through week 52; blinded treatment extension through week 116. |
Safety findings cover all active-dose groups
Gilead described emvistegrast as generally well tolerated. Adverse events occurred in 36% of participants across the combined treatment groups, compared with 37% in the placebo group, and were largely grade 2 or lower. Those safety percentages cover all three active doses, not just the 200 mg group highlighted in the efficacy results.
Serious adverse events occurred in four of 178 participants receiving emvistegrast, or 2%, and in no placebo participants. All were deemed unrelated to the study drug. Across the full study population, three of 238 participants discontinued because of adverse events.
Phase 3 is planned, not yet underway
Swati Tole, Gilead’s senior vice president of clinical development for inflammation, said the company plans to initiate a Phase 3 monotherapy study in 2027. She also described emvistegrast as a potential foundation for future combination approaches, rather than announcing a completed combination-treatment program.
The drug is designed to selectively inhibit the alpha-4-beta-7 integrin pathway. The mid-stage findings support further investigation, but Gilead cautioned that emvistegrast’s safety and efficacy have not been established. The reported results cover initial treatment, not proof of sustained disease control.
Conclusion
The next planned development milestone is the start of Gilead’s Phase 3 monotherapy study in 2027. That remains a company plan, while the current evidence establishes a positive 12-week Phase 2 result rather than an approved treatment.
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